The Role Work with the Clinical Operations team to support the conduct of clinical trials. Partner with Clinical Project Managers and Clinical Trial Managers to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines. Key Responsibilities Maintain the Trial Master Files (TMF) for assigned clinical trials (receipt, review, QC, tracking, and filing of required documents per SOPs). Ensure TMF is inspection ready. Provide TMF metrics to internal and external stakeholders. Work with cross-functional teams to adhere to the trial master oversight plan. Assist with development/maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits, and site payments. Assist Clinical Operations with CRO oversight as appropriate; attend/participate in Clinical Trial Working Groups as needed. Assist with reviewing monitoring visit reports. Review site-specific Informed Consent Forms. Track site feasibility questionnaires. Assist in planning meetings and events for the Clinical Operations team. Reconcile invoices to contracts/budget and assist with investigator site payments. Prepare and manage study communications (newsletters, study updates). Record, prepare, and distribute meeting minutes for assigned clinical trials (or as designated by VP of Clinical Operations). Support Clinical Trial Managers in preparing external/internal documentation in accordance with GCP and the study protocol. Desired Experience/Education and Personal Attributes Two years’ experience in Veeva Vault. Two or more years’ clinical operations experience (CRO and Sponsor experience desired). Essential knowledge of FDA regulatory requirements and ICH/GCP guidelines. Demonstrated efficiency partnering with CROs and vendors. Proficiency: Veeva TMF, Word, Excel, PowerPoint, SmartSheet. Proactive, efficient work in a fast‑paced, high‑change environment. Excellent written and oral communication skills. Outstanding organization skills. Bachelor’s degree desired (science/healthcare related). Location Open to candidates from any location; preference for East Coast locations. #J-18808-Ljbffr